Medtronic E5540MASKIT Instructions for Use

CD Horizon™ Spinal System M708348B414E Rev. H

2021-07-14

IMPORTANT INFORMATION ON THE CD HORIZON™ SPINAL SYSTEM

PURPOSE

The CD Horizon™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct
to fusion of the thoracic, lumbar, or sacral spine.

DESCRIPTION

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples,
and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked
into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These
constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws,
Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components
can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These
include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only
cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel,
medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non­pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples and
washers, GDLH™ rods, hooks, connectors and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and
Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: certain components
are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters.
Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and
associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD
Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium,
titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™
Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied
warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never

use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory

Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These
staples are not to be used in pediatric patients.

PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK
rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as
interbody fusion devices in the anterior spinal column.

To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system
or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and
neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

INDICATIONS

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an
adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation),
spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt
chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in
skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt
chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD
Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/
spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be
used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage
for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices
are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the
non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to
spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis,
trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction
System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™
indications.

CONTRAINDICATIONS

Contraindications include:

▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Medical or surgical conditions which would preclude the potential benefit of spinal implant surgery such as the presence of

congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count
(WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented metal allergy or intolerance.
▪ Cases not needing a bone graft and fusion.
▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ CD Horizon™ Spire™ plate and CD Horizon™ PEEK rods are specifically contraindicated for use in pediatric patients.
▪ Patients unwilling to follow postoperative instructions.
▪ Cases not described in the indications.

Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

POTENTIAL ADVERSE EVENTS

All adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of
potential adverse events includes:

▪ Early or late loosening of components.
▪ Disassembly, bending, or breakage of components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general corrosion) including

metallosis, staining, tumor formation, or autoimmune disease.

▪ Pressure on skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin

penetration, irritation, fibrosis, necrosis, or pain.

▪ Bursitis.
▪ Tissue or nerve damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
▪ Loss of neurological function (e.g. sensory or motor) including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, or development or continuation of pain, numbness,
neuroma, spasms, sensory loss, tingling sensation, or visual deficits.

▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,

irritation, arachnoiditis, muscle loss.

▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of spinal bone (including the sacrum, pedicles, or vertebral

body) or bone graft or bone graft harvest site at, above, or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, or mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stresses shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction, loss of bowel control, or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound

necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.)
▪ Change in mental status.
▪ Death.

Note: additional surgery may be necessary to correct some of these potential adverse events.

ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS

▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions and/or distorted anatomy).
▪ Pedicle screw malpositioning, with or without neurological or vascular injury.
▪ Proximal or distal junctional kyphosis.
▪ Pancreatitis.

WARNING

Safety and effectiveness of pedicle screw spinal systems were established only for spinal conditions with significant mechanical
instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity
of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurologic
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Safety and
effectiveness of this device for any other conditions are unknown. Implants are not prostheses. In the absence of fusion,
instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to
every day mechanical stresses.

These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. CD Horizon™ PEEK
rods are intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. This device is not a
prosthesis and is not intended for standalone use.

A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices
should also never be resterilized. Reprocessing or reuse may compromise the structural integrity of these implants and create a
risk of contamination of the implants which could result in patient injury, illness, or death.

ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS

Warning: safety and effectiveness of this device was not established for use as part of a growing rod construct. This device is
only intended to be used when definitive fusion is being performed at all instrumented levels.

Use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and
skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the
use of pedicle screws or increase risk of pedicle screw malpositioning and neurological or vascular injury. Patients not skeletally
mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational
spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.

Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in
pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.

ADDITIONAL WARNING FOR THE CD HORIZON™ SPIRE™ SPINOUS PROCESS PLATE

Consider the extent of decompression, as well as the amount of intact bone remaining on the spinous processes, when using
the CD Horizon™ Spire™ plate as the sole supplemental fixation for an interbody fusion procedure.

PRECAUTIONS

Implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in
the use of this pedicle screw spinal system because this is a technically demanding procedure presenting risk of serious injury
to patients.

Successful results are not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise results. This device system is not intended to be the sole means of spinal support.
Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can